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Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283486
Recruitment Status : Recruiting
First Posted : March 17, 2022
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
MyMD Pharmaceuticals, Inc.

Brief Summary:
The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines.

Condition or disease Intervention/treatment Phase
Sarcopenia Frailty Aging Drug: MYMD-1 600MG Drug: MYMD-1 750mg Drug: MYMD-1 900mg Drug: MYMD-1 1050mg Drug: placebo 600mg Drug: placebo 750mg Drug: placebo 900mg Drug: placebo 1050mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind clinical trial.
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Phase 2 Study to Investigate the Efficacy, Tolerability and Pharmacokinetics of MYMD1 in the Treatment of Participants Aged 65 Years or Older With Chronic Inflammation Associated With Sarcopenia/Frailty
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : November 10, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1: MYMD1 600mg
Subjects randomly assigned to the MYMD1 600mg cohort
Drug: MYMD-1 600MG
Cohort 1: 600mg drug
Other Name: MYMD1 600mg

Placebo Comparator: Cohort 1: Placebo 600mg
Subjects assigned to the 600mg placebo group
Drug: placebo 600mg
Cohort 1: 600mg placebo
Other Name: placebo-600mg

Experimental: Cohort 2: MYMD1 750mg
Subjects randomly assigned to the MYMD1 750 cohort
Drug: MYMD-1 750mg
Cohort 2: 750mg drug
Other Name: MYMD1 750mg

Placebo Comparator: Cohort 2: Placebo 750mg
Subjects assigned to the 750mg placebo group
Drug: placebo 750mg
Cohort 2: 750mg placebo
Other Name: placebo-750mg

Experimental: Cohort 3: MYMD1 900mg
Subjects randomly assigned to the MYMD1 900mg cohort
Drug: MYMD-1 900mg
Cohort 3: 900mg drug
Other Name: MYMD1 900mg

Placebo Comparator: Cohort 3: Placebo 900mg
Subjects assigned to the 900mg placebo group
Drug: placebo 900mg
Cohort 3: 900mg placebo
Other Name: placebo-900mg

Active Comparator: Cohort 4: MYMD1 1050mg
Subjects randomly assigned to the MYMD1 1050mg cohort
Drug: MYMD-1 1050mg
Cohort 4: 1050mg drug
Other Name: MYMD1 1050mg

Placebo Comparator: Cohort 4: Placebo group 1050mg
Subjects assigned to the 1050mg placebo group
Drug: placebo 1050mg
Cohort 4: 1050mg placebo
Other Name: placebo-1050mg




Primary Outcome Measures :
  1. Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 [ Time Frame: Screening ]
    Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment

  2. Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 [ Time Frame: Day 1 ]
    Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment

  3. Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 [ Time Frame: Day 7 ]
    Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment

  4. Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 [ Time Frame: Day 14 ]
    Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment

  5. Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 [ Time Frame: Day 21 ]
    Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment

  6. Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 [ Time Frame: Day 28 ]
    Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment

  7. To evaluate the PK of oral doses of MYMD1 capsules [ Time Frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs] ]
    Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time, compared across treatment and placebo groups.

  8. To evaluate the PK of oral doses of MYMD1 capsules [ Time Frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs] ]
    Pharmacokinetics: Cmax - Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.

  9. To evaluate the PK of oral doses of MYMD1 capsules [ Time Frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs] ]
    Pharmacokintetics: tmax - Time to Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.

  10. To evaluate the PK of oral doses of MYMD1 capsules [ Time Frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs] ]
    Pharmacokinetics: t1/2 - Time to metabolize 1/2 of dose (eg, half-life) of drug substance, measured in blood plasma, compared across treatment and placebo groups.

  11. To evaluate the PK of oral doses of MYMD1 capsules [ Time Frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs] ]
    Pharmacokinetics: CL/F - Oral Clearance of the drug substance (CL/F), compared across treatment and placebo groups.

  12. To evaluate the PK of oral doses of MYMD1 capsules [ Time Frame: Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs] ]
    Pharmacokinetics: Volume of Distribution (V2/F ) - Volume of Distribution of the drug substance (V2/F), compared across treatment and placebo groups.

  13. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 1 (predose) ]
    urine sample collection for presence of parent drug - MYMD1

  14. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 1 (0-4 hrs post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  15. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 1 (4-8 hrs post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  16. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 1(8-24hrs post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  17. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 7 (predose) ]
    urine sample collection for presence of parent drug - MYMD1

  18. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 7 (0-4 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  19. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 7 (4-8 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  20. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 7 (8-24hrs post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  21. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 14 (predose) ]
    urine sample collection for presence of parent drug - MYMD1

  22. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 14 (0-4 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  23. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 14 (4-8 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  24. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 14 (8-24 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  25. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 21 (predose) ]
    urine sample collection for presence of parent drug - MYMD1

  26. To evaluate the PK of oral doses of MYMD1 capsules [ Time Frame: Day 21 (0-4 hrs post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  27. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 21 (4-8 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  28. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 21 (8-24 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  29. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 28 (pre dose) ]
    urine sample collection for presence of parent drug - MYMD1

  30. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 28 (0-4hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  31. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 28 (4-8 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1

  32. To evaluate the PK (urine) of oral doses of MYMD1 capsules [ Time Frame: Day 28 (8-24 hours post dose) ]
    urine sample collection for presence of parent drug - MYMD1


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 28 days ]
    Safety and Tolerability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 99 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 65 years or older, at the time of signing the ICF

    Type of Participant and Disease Characteristics

  2. Elevated biomarkers of inflammation (serum IL-6 level ≥2.5 pg/mL and/or sTNFR1 level ≥1500 pg/mL)
  3. Low gait speed ≤ 0.8 m/s
  4. Short Physical Performance Battery (SPPB) score ≤8

    Weight

  5. Body weight ≥35 kg Other
  6. Adequate dietary intake
  7. Able to complete a 4-meter timed walk
  8. Assessment and documentation of sarcopenia-related loss of muscle mass based on Dual-energy X-ray absorptiometry (DXA) -derived appendicular skeletal muscle mass index (ASMI) measurements.

    Reproductive Status

  9. Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  10. Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP)

    Informed Consent

  11. Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

  1. Taking anti-inflammatory drugs on a daily basis. Note: If the participant has been stable on their antidepressant regimen for at least 3 months and agrees not to increase the medicine for the 28 days of treatment in the trial, they may be allowed into the study
  2. Currently tobacco users or those who used tobacco within 30 days of study entry
  3. Dementia, encephalopathy or any medical condition impacting cognition
  4. Medical conditions that would impact mobility testing or handgrip strength including
  5. Rheumatoid arthritis, any autoimmune condition, Parkinson's disease, muscular dystrophy, cerebral vascular accident, lower or upper extremity neuropathy, major skeletal joint deformity, upper extremity joint dysfunction, partial or complete upper extremity amputation or missing anatomy impacting grip, history of pain with walking, gout, chronic obstructive pulmonary disease, congestive heart failure, exercise induced angina, lower extremity amputation (partial or complete) or missing anatomy impacting walking, recent surgery or hospitalization (past 3 months); lower or upper extremity fracture in the past 6 months, lower or upper extremity tendinitis, diagnosis of cancer other than basal cell carcinoma, dialysis dependent renal disease, Meniere's disease, spinal cord fracture or compression, paraplegia or quadriplegia or any other medical condition that in the opinion of the Investigator would impair measurement of a 6-minute walk or handgrip strength
  6. A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (eg, stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management)
  7. Requires regular assistance from another person for general activities of daily living (eg, bathing, dressing, toileting)
  8. History of cardiac conduction abnormalities, arrhythmias, and/or bradycardia
  9. Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening
  10. Any underlying muscle disease including active myopathy or muscular dystrophy
  11. Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (eg, dilated cardiomyopathy)
  12. Type I diabetes or uncontrolled Type 2 diabetes
  13. Chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min)
  14. History of confirmed chronic obstructive pulmonary disease with a severity Grade >2 on the Medical Research Council Dyspnea Scale
  15. Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/day prednisone equivalent
  16. Known history or presence of severe active acute or chronic liver disease (eg, cirrhosis)
  17. Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (eg, angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening
  18. Active cancer (ie, under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (eg, early-stage prostate or breast cancer, carcinoma in situ of the uterine cervix)
  19. Any known chronic active infection
  20. Use of any anxiolytics, cannabis or opioid medications
  21. Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within 6 months of entering this study
  22. A score of <23 on the Mini Mental Status Exam
  23. Treatment with any prescription or investigational drugs, devices or chemotherapy, or any other therapies for sarcopenia
  24. Use of medications with narrow therapeutic ranges within 48 hours of the first dose of study treatment
  25. Current use of systemic steroids or use of systemic steroids within 90 days of treatment except for prophylaxis against imaging contrast dye allergy or replacement-dose steroids in the setting of adrenal insufficiency (providing this is ≤10 mg/day prednisone or equivalent; see Appendix 5 for steroid conversion table), or transient exacerbations of other underlying diseases such as chronic obstructive pulmonary disease requiring treatment for <3 weeks
  26. Vaccination with live vaccines while on study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283486


Contacts
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Contact: Director of Regulatory Affairs (813) 864-2566 jbrager@mymd.com

Locations
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United States, Florida
Clinical Research of West Florida, Inc Recruiting
Clearwater, Florida, United States, 33765
Contact: Jamee Moran, MS    727-466-0078 ext 229    JMoran@crwf.com   
Principal Investigator: Leonard Dunn, MD         
Clinical Research of West Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Kyndall Carter    813-870-1292 ext 130    KCarter@crwf.com   
Principal Investigator: Lon Lynn, DO         
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Jackie Langdon    410-550-2052    jlangdon@jhmi.edu   
Principal Investigator: Jeremy Walston, MD         
Sponsors and Collaborators
MyMD Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Leonard Dunn, MD Clinical Research of West Florida
Principal Investigator: Lon Lynn, DO Clinical Research of West Florida
Principal Investigator: Jeremy Walston, MD Johns Hopkins University
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Responsible Party: MyMD Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05283486    
Other Study ID Numbers: MyMD-PK-003
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MyMD Pharmaceuticals, Inc.:
frailty
aging
sarcopenia
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Inflammation
Frailty
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical